Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
Status:
NOT_YET_RECRUITING
Trial end date:
2032-03-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \< 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safety and efficacy of infigratinib in children \< 3 years old with ACH at the selected dose.